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material_safety_data_sheet_letter_new_.doc
05% OCUFLOX® (Ofloxacin Ophthalmic Solution) 0.3% SANCTURA® (trospium chloride), 20 mg tablets Ofloxacin SANCTURA XR® (trospium chloride), 60 mg tablets OPHTHETIC® (Proparacaine HCl Ophthalmic Solution) 0.5% Trimethoprim Sulfate and Polymyxin B Sulfate, 0.1% OPTIVE™ Lubricant Eye Drops VIVITE™ Daily Antioxidant Facial Serum ...
author: hutton_ronald
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material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
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Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
OO units Pentagastrin 0.006 mg Pentamidine Isethionate 4.00 mg Pentobarbital Sodium Injection 6.00 mg Pentazocine Lactate Injection 0.86 mg Perphenazine 0.14 mg Phenobarbital Sodium Injection 20.00 mg Phenolsulfonphthalein 0.09 mg Phentolamine Mesylate 0.86 mg Pentylenetetrazol 7.14 mg Phenylephrine HCI 0.20 mg Phenytoin Sodium Injection 20.00 mg Physostigmine Salicylate 0.06 mg...
author: FDA / CBER
subject: December 1987 Guideline
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
AMIODARONE HCL 3506 24-Apr-79 BAXTER ONCOLOGY GMBH IFOSFAMIDE 3507 27-Apr-79 GEDEON RICHTER LTD VINCRISTINE SULFATE 3513 08-Mar-79 FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE 3516 30-Mar-79 DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 3524 08-Feb-79 DINAMITE DIPHARMA SPA "CYPROHEPTADINE HCL, USP" 3529 30-May-79 AVENTIS PHARMA SA PREDNISOLONE ACETATE 3531 14-Mar...
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Mercury in Drug and Biologic Products
Retired Persons Oxymetazoline Nasal Spray PMA.002 - American International Chemical Thimerosal (bulk chemical) TM 100 - American International Chemical Thimerosal (bulk chemical) TM 100 - American International Chemical Thimerosal USP 97% (bulk chemical) TM 97 - American Pharmaceutical 12 Hour Nasal Solution PMA NS - Appletree Markets Long Lasting Nasal Spray PMA NS * Bausch & Lomb...
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Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 5
author: FDA / CBER
subject: December 1987 Guideline
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Prescription and Over-the-Counter Drug Product List: 2/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
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Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
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Prescription and OTC Drug Product List 8/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
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Prescription and OTC Drug Product List 1/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
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Prescription and OTC Drug Product List 1/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
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Prescription and OTC Drug Product List 5/2001
Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
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Prescription and OTC Drug Product List 2/2001
PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
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DDPA December 1995
20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL ANTI...
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Prescription and OTC Drug Product List 7/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 7: July 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE - ADD - CALFACTANT TABLET; ORAL - ADD - INJECTABLE; INJECTION BUTALBITAL,ACETAMINOPHEN AND CAFFEINE - ADD - INFASURF PRESERVATIVE FREE - ADD - AB + MIKART 500MG...
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1997 Abbreviated New Drug Applications (Generic Drugs)
74579 11/26/97 4/7/99 Bleomycin Sulfate - Pharmacia 064084 06/03/1996 8/4/2003 Brompheniramine Chromalloy Pharmaceuticals 085888 04/26/1978 8/6/2003 Bumetanide Injection USP, 0.25 mg/mL
71804 5/29/1997 4/1/1999 Desmopressin Acetate Injection 4mg/ml [801 KB] Gensia Laboratories, Ltd
Perrigo Company 40167 9/15/96 4/13/99 Epifoam/Hydrocortisone Acetate 1% and...
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FDA Drug Approvals List- December 1998
Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric
Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
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Drug Approvals - M
NDA 13-422/S-035 4/17/03 - - - Maxipime (Cefepime Hydrochloride) Injection,-Rx Bristol-Myers Squibb NDA 50-679/S-21 3/17/03 3/26/03 3/26/03 Maxipime (Cefepime Hydrochloride) Injection,- Bristol-Myers Squibb NDA 50-679/S-009, S-014 and S-018 8/21/02 8/26/02 - Maxipime (Cefepime Hydrochloride) Injection Bristol-Myers Squibb NDA 50-679/S007 1/27/99 - - 7/18/01 Maxitrol (neomycin...
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Drug Approvals - N
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Nabumetone Tablets, 500 mg, Rx- Second (Tentative Approval) Copley Pharmaceutical, Inc
ANDA 76-302 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved Eon Labs, Inc
ANDA 76-072 1/30/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg,...
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Prescription and OTC Drug Product List 11/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A- AB ANABOLIC 325MG;50MG;40MG;30MG...
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Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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Prescription and OTC Drug Product List 6/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
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